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NCT05448482

Hybrid Versus Synthetic TOT for Treatment of SUI

Status unknown NA Last updated 7 July 2022
What this trial tests

NA trial testing Transobturator tape in Female Stress Incontinence in 50 participants. Status unknown.

Timeline
5 January 2021
Primary endpoint
5 January 2023
15 January 2023

Quick facts

Lead sponsorAlexandria University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment50
Start date5 January 2021
Primary completion5 January 2023
Estimated completion15 January 2023
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Alexandria University

Who can join

Adults 20 to 70, female only, with Female Stress Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective study is conducted on female patients presenting with SUI at Alexandria main university hospital. Patients with neurogenic voiding dysfunction, history of anti-incontinence surgery, urge-predominant MUI, urogenital cancer, pelvic irradiation, body mass index more than 40 kg/m2 and more than stage 1 POP are excluded. Patients are randomized into 2 groups, one group will be subjected to h\_TOT, and the second group to conventional TOT. Patients are subjected to PGI and UDI-6 questionnaires and a urodynamic study before and 6 months after the both surgery. Success is defined as: no subjective complaint of SUI, negative cough stress test and no leakage on UDS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Transobturator tape

Trials testing the same drug.

Other Alexandria University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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